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Completed

NCT Number: NCT00586586

Effectiveness Study of CBT for Anxiety in Children

The study aims to evaluate the effectiveness of a cognitive behaviour therapy program (FRIENDS) for anxiety disorders in children aged 8-15 years who have been referred to child and adolescent mental health clinics in Western Norway.

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Key information

Conditions

Separation Anxiety Disorder Anxiety Disorders Anxiety, Separation Generalized Anxiety Disorder Mental Disorders Neurodevelopmental Disorders Phobia, Social Phobic Disorders Social Anxiety Disorder

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

About this study

Cognitive behaviour therapy (CBT) has been shown to be an efficacious treatment for anxiety disorders in youths when delivered in university settings. However, there is a lack of studies evaluating the effectiveness of CBT in regular clinical settings.

The current study will compare a CBT program developed for anxiety in youths (the FRIENDS program by Paula Barrett, Australia), with a wait-list control condition. Group and individual treatment will also be compared in the study. Groups will be divided by age, with younger including 8-12-year-olds, and older 12-15-year-olds. Parents are also involved at the end of all therapy sessions, as well as in separate parent sessions. Assessment and treatment is delivered by clinicians working in seven outpatient clinics in Western Norway.

There will be 10 therapy sessions, with booster sessions 4 and 12 weeks later. Effectiveness will be evaluated post-treatment, and at 1 and 5 years follow-up. The study will have a randomized design. Children randomized to the wait-list condition will be offered treatment if they still meet inclusion criteria after the waiting period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meeting DSM-IV criteria for separation anxiety, social anxiety or generalized anxiety disorder based on the ADIS interview schedule

Exclusion criteria

  • Pervasive developmental disorders, Selective mutism, Mental retardation
  • Having severe obsessional/compulsive, conduct or language problems.

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.

Other names: FRIENDS

Primary outcomes

  1. Anxiety disorders according to the ADIS-IV C/P interview

    Time frame: Post-treatment and 1 and 5 year follow-up

    Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.

Secondary outcomes

  1. Anxiety symptom score according to the Spence Children Anxiety Scale

    Time frame: Post-treatment, 1 and 5 year follow-up

  2. Depressive symptoms according to the Mood and Feelings Questionnaire

    Time frame: Post-treatment, 1 and 5 year follow-up

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University of Bergen

Registry information

Official study title

Assessment and Treatment - Anxiety in Children and Adults (Child Part)

Acronym: ATACA

Important dates

Study start
2008
Primary completion
2012
Study completion
2014
First posted
Jan 4, 2008
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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